It was reported that during a procedure, the surgeon broke the bolt of the tibial impactor.No piece fell into the patient.The surgery was completed with another device without any complications.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, no patient harm or further outcome was reported.Due diligence is in progress for this complaint; no further additional information or product has been received.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h3, h4, h10.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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This follow-up report is being submitted to relay additional and corrected information.Visual examination of the returned product verified item and lot numbers matches the complaint.Scuffs and scratches noticed on the part.Dents and dings on strike plate.Bolt head is broken off the bolt.A review of the device manufacturing records confirmed no abnormalities or deviations.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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